Appendix: Reference Table of HT Brand Names This is a full reference table in alphabetical order, of Brand Name drugs used in HT. It is the basis for prescription advice throughout this handbook. Drug name Company Drug type Activella Pharmacia Micronized Estradiol, Norethindrone Route of administration Oral E/P combination Alora Watson 17beta-estradiol Transdermal patch Cenestin Duramed/ Synthetic Solva conjugated estrogens Climera Berlex 17beta-estradiol Transdermal patch CombiPatch Aventis 17beta-estradiol and norethindrone Esclim Estrace Women First Warner- Chilcot Usual daily dosages 1 mg 17betaestradiol, 0.5 NE, continuous daily dosing 0.05, 0.075, 0.1 mg. 2x/week Oral 0.625, 0.9, 1.25 mg/continuous daily dosing 0.025, 0.05, 0.1 mg. One time per week Transdermal 0.05 mg 17betaestradiol patch/ and combined 0.14 mg NE, 0.05 mg 17betaestradiol and 0.25 mg NE. Twice per week 17beta-estradiol Transdermal 0.025, 0.0375, 0.05, 0.075, 0.1 mg. Twice per week. 17beta-estradiol (micronized0 Vaginal estrogen (describe more) 0.5 mg, 1 mg daily to start, then 1-3 times per week (continued) K. Sherif, Hormone Therapy: A Clinical Handbook, DOI 10.1007/978-1-4614-6268-2, Springer Science+Business Media New York 2013 119
120 Hormone Therapy Drug name Company Drug type Route of administration Usual daily dosages Estraderm Novartis 17beta-estradiol Transdermal 0.05, 0.1, twice per week Estratab Solvay Esterified estrogens Estratest Estratest-HS Solvay Conjugated equine estrogen and methyltestosterone (MT) Oral Oral combined cyclic estrogen/ testosterone Estring Pharmacia Estradiol Vaginal Estrogen Ring Fern HT Parke- Davis Conjugated equine estrogens and medroxyprogesterone acetate (MPA), ethinyl estradiol (EE), and norethindrone Menest Monarch Esterified estrogens Oral combined continuous estrogen/ progesterone 0.3, 0.625, 2.5 mg/ continuous daily dosing 12.5 mg CEE plus 2.5 mg MT; cyclic dosing: 3 week on, 1 week off 2 mg reservoir; replace every three months 5 m g EE plus 1 mg NE; continuous daily dosing Oral 0.3, 0.625, 1.25, 2.5 mg/cyclic dosing: 3 weeks on, 1 week off Ogen Pharmacia Estropipate Oral 0.625, 1.25, 2.5 mg/continuous daily dosing or cyclic dosing Ortho-EST Ortho- Prefest Ortho- Dienestrol Women First Ortho- McNeil Ortho- McNeil Estropipate Oral 0.625, 1.25, 2.5 mg/ continuous Micronized estradiol and norgestimate Dienestrol Oral combined estrogenprogestin continuous 1 mg 17betaestradiol (continuous) and 0.09 mg norgetimate (pulsed in 3-day cycles) Vaginal 0.1 mg/gram, daily (continued)
Appendix: Reference Table of HT Brand Names 121 Drug name Company Drug type Premarin Premarin Cream PremPhase PremPro Wyeth- Ayerst Wyeth- Ayerst Wyeth- Ayerst Wyeth- Ayerst Conjugated equine estrogens (CEE) Conjugated equine estrogens Conjugated equine estrogens and medroxyprogesterone acetate (MPA), ethinyl estradiol (EE), and norethindrone Route of administration Usual daily dosages Oral 0.3, 0.45, 0.625, 0.9, 1.25 mg/ continuous daily dosing or cyclic dosing Vaginal Oral combined cyclic estrogenprogestin Conjugated Oral equine estrogens Combined and medroxyprogesterone acetate progestin estrogen- (MPA), ethinyl estradiol (EE), and norethindrone 0.625 mg/gram, daily Days 1 14: 0.625 mg CEE Days 15 28: 0.625 mg CEE plus 5 mg MPA 0.625 mg CEE plus 2.5 MPA, 0.625 mg CEE plus 5 mg MPA Vagifem Pharmacia Estradiol Vaginal First 2 weeks: 25 m g tablets daily Then 25 mg tablets two times per week Vivelle Dot Novartis 17beta-estradiol Transdermal patch 0.0375, 0.05, 0.075, 0.1 mg. Two times per week Adapted from John David Gordon MD et al, Obstetrics, Gynecology and Infertility: Handbook for Clinicians, 6th edition (Scrub Hill Press, 2007)
Index A Abnormal menstrual bleeding breakthrough bleeding, 87 combined HT regimens, 86 differential diagnosis, 85 evaluation, 86 HT and periods, 86 American Association of Clinical Endocrinology (AACE), 34 36 Androgen, 27 Antidepressants and anticonvulsants, 95 Autoimmune disease, 94 B Bioidentical hormones compounded bioidentical hormones advantages, 46 compounding pharmacy/ pharmacist, 47 definitionfi, 45 46 FDA-approval, 47 pharmacy location navigation, 47 48 definitionfi, 11 12 designer estrogen phenomenon, 49 50 estrogen forms, 48 invention, 45 medical associations, 50 misconceptions and facts, 47 natural HT, 48 49 natural or semi-synthetic sources, 43, 44 standardized bioidentical hormones, 45, 46 Suzanne Somers approach, 49 synthetic sources, 43, 44 types, 45 Breakthrough bleeding, 80 82, 87 Breast cancer adverse effects, 31 32 contraindications, 73 heart disease and, 108 109 risks, 104 Breast tenderness, 79, 80 C Cardiovascular disease, 29 30 Cognition HRT benefitsfi, 31 mood and, 41 42 Colorectal cancer, 29 Compounded bioidentical hormones advantages, 46 compounding pharmacy/ pharmacist, 47 definitionfi, 45 46 FDA-approval, 47 pharmacy location navigation, 47 48 Conjugated equine estrogen (CEE), 43 K. Sherif, Hormone Therapy: A Clinical Handbook, DOI 10.1007/978-1-4614-6268-2, Springer Science+Business Media New York 2013 123
124 Index D Dementia, 30 Diethylstilbestrol (DES), 101 102 E Endometrial cancer, 85, 103 104 Estradiol, 91, 109 110 bioidentical hormones, 11 12, 49 drug interactions, 75 76 estrogen deficiency, 11 vs. estrone and estriol, 8 9 hot flushes, 65 patches and gels, 58 59 perimenopause, 4 5 spray, 59 60 transdermal vs.oral, 64 vulvar discomfort and/or vaginal discomfort, 70 Estrogen and Thromboembolism (ESTHER) study, 54 55 bioidentical hormones, 12, 55 drug interactions, 81 82 estrogen deficiency, 11 vs. estrone and estriol, 8 9 hot flushes, 71 patches and gels, 64 65 perimenopause, 4 5 spray, 66 transdermal vs.oral, 70 vulvar discomfort and/or vaginal discomfort, 76 Estrogen, 60 61 See also Transdermal estrogen AACE guidelines, 34 36 bioidentical hormones, 43 45 breakthrough bleeding, 80 82 breast cancer, 31 32 deficiency, 11, 27 effects, 10 estradiol, 8 9 estrone, 9 FDA approvals, 22 history blood clots, 109 confusions and controversy, 99 diethylstilbestrol (DES), 101 102 heart disease, 106 108 HERS study, 108 109 Nurses Health Study, 106 107 osteoporosis, 105 106 PEPI trial, 107 108 premarin, 108 synthetic estrogen manufacture, 100 101 uterine/endometrial cancer, 103 104 WHI (see Women s Health Initiative (WHI)) youthfulness and femininity, 102 103 low, 80 menopausal hormone, 11 ovarian cancer, 33 principles of practice, 18, 19 Estrogen. See also Transdermal estrogen AACE guidelines, 38 40 bioidentical hormones, 49 51 breakthrough bleeding, 86 88 breast cancer, 35 36 deficiency, 11, 31 effects, 10 11 estradiol, 8 9 estrone, 9 FDA approvals, 26 history blood clots, 115 confusions and controversy, 105 diethylstilbestrol (DES), 107 108 heart disease, 112 114 HERS study, 114 115 Nurses Health Study, 112 113 osteoporosis, 111 112 PEPI trial, 113 114 premarin, 114 synthetic estrogen manufacture, 106 107 uterine/endometrial cancer, 109 110
Index 125 WHI (see Women s Health Initiative (WHI)) youthfulness and femininity, 108 109 low, 86 menopausal hormone, 11 ovarian cancer, 37 principles of practice, 20, 21 F FDA approvals and contraindications, 22 Follicle stimulating hormone (FSH), 7, 74 H Heart and Estrogen/Progestin Replacement Study (HERS study), 108 109 Heart disease Nurses Health Study, 106 107 PEPI trial, 107 108 prevention, 117 Hormone replacement (HRT) AACE, 34 36 adverse effects breast cancer, 31 32 endometrium, 33 mammography, 32 ovarian cancer, 33 stroke, 31 venous thromboembolism, 31 androgen, 27 benefitsfi cardiovascular disease, 29 30 cognition, 31 colorectal cancer, 29 connective tissues, 29 dementia, 30 postmenopausal osteoporosis, 28 30 urogenital symptoms, 27 28 class effect, risks and benefitsfi, 25 counseling, 26 duration, 25 early menopause, 25 FDA approvals and contraindications, 22 governing principles, 24 25 NAMS guidelines, 23 nonhormonal therapies, 33 34 progestogen, 26 27 safety considerations, 26 27 WHI, 21 Hormone routes of administration comparison table, 60 cream, 58 59 estradiol spray, 59 60 gel, 58 oral, 58 patches, 58 pellets, 59 transbuccal lozenges/ trouches, 59 transdermal, 58 vaginal, 58 WHI evaluation, 57 Hormone (HT) antidepressants and anticonvulsants, 95 autoimmune disease, 94 bioidentical hormones, 11 12 definitionfi, 11 duration, 89 90 estrogen history (see Estrogen, history) estrogen loss and aging, 12 liver s role, 13 monitoring effects and side effects breakthrough bleeding, 80, 82 contraindications, 82 corrective treatment, 80, 81 drug interactions, 82 83 menopause symptoms, 79 symptomatic signs, 80 prescription, 19 beginning of, 73 contraindications and cautions, 73 74 drugs interactions, 75 76 duration of treatment, 74 FSH and BMI, 74
126 Index Hormone (HT) (cont.) side effects, 75 surgical menopause, 74 75 returning to, 91 routes of administration, 18 testosterone role in, 9 10 thyroid disease, 93 94 uterine fibroidsfi, 93 withdrawal, 90 91 Hot flushesfl, 40, 65 HRT. See Hormone replacement (HRT) HT. See Hormone (HT) Hypothyroidism, 93 I Intermenstrual spotting, 79 International Menopause Society, 24 K Kronos Early Estrogen Prevention (KEEPS) study, 55 L Luteal out-of-phase (LOOP), 11 Late reproductive age, 14 Luteal out-of-phase (LOOP), 11 M Mammography, 32 Menopause age, 6 cardiovascular disease, 29 30 definitionfi, 6 early and natural menopause, 7 8, 25 estrogens (see Estrogens) HT (see Hormone (HT)) perimenopause definitionfi, 4 estradiol level patterns, 4 5 symptoms, 5 6 (see also Perimenopausal symptoms) postmenopause, 7 premenopause, 3 principles of practice, 17 19 progesterone (see Progesterone) STRAW definitionsfi, 3, 4 reproductive stages identificationfi, 7, 8 surgical and medical menopause, 7 Mood and cognition, 41 42 N Night sweats, 40 North American Menopause Society (NAMS), 23 Nurses Health Study, 106 107 O Oral estrogen, 23, 71 Osteoporosis postmenopausal, 28 29 prevention, 105 106, 117 Ovarian cancer, 33 P Patches, 53, 58 Perimenopausal symptoms cognitive issues and mood swings, 65 commonly reported, 39 40 estradiol levels and, 63 FDA-approved hormone formulations, 71 heavy menstrual bleeding, 68 high, 80 hot flushesfl, 65 low libido, 66 menopause and postmenopause, 40 mood and cognition, 41 42 premenstrual symptoms, 68 prescribing regimens, 64 65 progestogens, 66 67 sleep issues, 41
Index 127 transdermal estrogen, 66 67 ( see also Transdermal estrogen) urogenital symptoms, 41 vasomotor symptoms, 40 vulvar discomfort and/or vaginal discomfort, 70 Perimenopause, 14 definitionfi, 4 estradiol level patterns, 4 5 symptoms, 5 6 (see also Perimenopausal symptoms) Postmenopausal bleeding, 85 Postmenopausal Estrogen/Progestin Interventions (PEPI) trial, 107 108 Postmenopausal osteoporosis, 28 29 Premarin, 108 Premenopause, 3 Progesterone bioidentical hormones, 45, 48 breakthrough bleeding, 80 cream and pellets, 58, 59 effects, 13 estrogen deficiencyfi, 11 menopause, 7 perimenopause, 4 principles of practice, 18 production, 9 progestins and, 68 69 progestogen and progestin, 12 receptors location, 12 Progestogen, 26 27, 68 69 S Sleep issues, 41 Stages of Reproductive Aging Workshop (STRAW) definitionsfi, 3, 4 identification methodfi, 7, 8 Stroke, 31 Suzanne Somers approach, 49 T Testosterone cream and pellets, 58, 59 roles in HT, 9 10 Thyroid disease, 93 94 Transbuccal lozenges/trouches, 59 Transdermal estrogen advantages, 53 contraindications, 54 ESTHER study, 54 55 formulations, 68 69 KEEPS study, 55 U Urogenital symptoms, 27 28, 41 Uterine/endometrial cancer, 103 104 Uterine fibroidsfi, 93 V Vaginal estrogen creams, 58, 70 Vasomotor symptoms, 33 34, 40 Venous thromboembolism, 31 Vivelle, 44, 46 W Women s Health Initiative (WHI), 21 criticisms, 115 116 estrogen-only/surgical menopause section, 110 111 lifestyle changes, 117 outcomes, 110, 111 postmenopausal women and HT, 116 post-whi, 112 protocol, 109 110 younger users, 116 Women s Health Initiative Memory Study (WHIMS), 110